fosamax law suit
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Business Editors/Health/Medical Writers
JERUSALEM–(BUSINESS WIRE)–Aug. 29, 2003
Teva Pharmaceutical Industrie
The FDA has approved two supplemental NDAs submitted by Merck revising labeling for Fosamax (alendronate sodium) tablets. The first change adds clinical efficacy and safety information from the four-year Fracture Intervention Trial to the Clinical Studies subsection of the Clinical Pharmacology section of the …
By 2000 the FDA had received 139 spontaneous reports through the MedWatch system of osteonecrosis of the jaw (ONJ) in cancer patients treated with intravenous (IV) bisphopshonates, either IV pamidronate (Aredia) or IV zolendronate (Zometa). Spontaneous reports cannot prove causality, as patients with cancer (and some without cancer) develop spontaneous ONJ, and hundreds of thousands of cancer patients had been treated with these IV bisphosphonates. Despite the fact that many millions of patients had been treated with oral bisphosphonates such as Fosamax and Actonel, not one of the 139 MedWatch reports involved a patient treated only with an oral bisphosphonate. In order to dtermine if the IV bisphosphonates were causally related to ONJ, the FDA asked Novartis, the manufacturer of both drugs, to screen their completed Phase 3 program databases with a collection of MEDdra terms designed to catch all possible cases of ONJ (most of the terms were not specific for ONJ, but coded for “jaw pain”, “jaw infection”, etc.). Novartis returned to the ODAC (Oncology Drugs Advisory Committee) meeting in 2004, and presented data demonstrating a number of “hits” to any of these terms as well as 6 cases of actual ONJ; all 6 of the ONJ cases occurred in patients treated with pamidronate (Aredia) or zolendronate (Zometa) vs no cases in the placebo group. This proves causality, and FDA required both drugs to include a warning in their label that use of the drugs increases the risk of ONJ.
At the 2004 ODAC meeting the number of spontaneous reports had increased since 2000, and although almost all of the reports remained in cancer patients treated with one of the IV bisphosphonates 13 of the reports were in patients taking oral alendronate or risedronate, most of which were reported on September 24, 2004 in the Journal of Oral and Maxillofacial Surgury. Although this small number of reports (several of which do not appear to represent true ONJ) do not remotely indicate causality, given the millions of patients who have been treated with alendronate and risedronate, in order to be cautious the Food and Drug Administration (FDA) asked the manufacturer of the oral bisphosphonates (Merck for Fosamax, Procter & Gamble and Aventis for Actonel, and Roche and GSK for Boniva) to issue a warning to health care professionals of the potential that alendronate, risedronate and ibandronate and their brand name equivalents, Fosamax, Actonel and Boniva might increase the risk of ONJ. When the alendronate Fracture Intervention Trial database (containing almost 25,000 patient-years, larger than the pamidronate and zolendronate databases) was screeened with the same MEDdra terms, not a single case of ONJ was identified. A total of only 10 patients had a “hit” to any of the terms (none of which were ONJ), of whom 4 were in the Fosamax group and six were in the placebo group. Three of the 10 patients had adverse events that involved the jaw, none of which were ONJ, and all three patients were in the placebo group.
Despite the fact that no data links the oral bisphosphonates (which are used at much lower doses than the IV bisphosphonates) causally to ONJ, product liability attorneys immediately filed suit maintaining this condition is far more widespread than initially indicated, and maintaining that their claimants’ ONJ is a direct result of the use of alendronate. Merck has stated the “underlying cause” of osteonecrosis of the jaw is “uncertain”, though it might be triggered by a traumatic event like tooth extraction or oral surgery. As of May 13, 2007, hundreds of cases had been filed against Merck alleging Fosamax-induced ONJ. Most of the cases are consolidated for pretrial purposes in the United States District Court for the Southern District of New York (MDL 1789). The first case is set to be tried in late 2008 before the Honorable John F. Keenan, District Judge for the Southern District of New York.
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